Kornimate/medical-research-clean huggingface dataset:
anti cytokine combination therapy with daclizumab and infliximab for treatment of steroid refractory acute gvhd

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to see whether serious graft versus host disease which is not well controlled with steroid treatment can be controlled with therapy with both daclizumab and infliximab. we hypothesize that a combination of daclizumab and infliximab will more effectively treat graft versus host disease than therapy with a single drug. the study also looks at whether chronic graft versus host disease develops, and survival at 6 and 9 months post-treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of steroid refractory agvhd defined as no response to methylprednisolone at 2 mg/kg for 1 week or disease progression after 72 hours of methylprednisolone at this dose. potential subject will have had no decrease in any gvhd organ staging as follows: * skin rash, if present, does not decrease by one stage. this is based on the percent of the body involved with rash, plus presence of bullae and desquamation. * gut gvhd, if present, does not decrease by one stage. this is based on volume of diarrhea, pain, and ileus. * upper gastrointestinal gvhd, if present, does not resolve. * liver gvhd, if present, does not decrease by one stage. this is based on total bilirubin level. * prior allogeneic hematopoietic stem cell transplantation using bone marrow, peripheral blood or umbilical cord cells. recipients of standard as well as nonmyeloablative transplants are eligible. * no previous immune suppressive therapy given for treatment of acute gvhd except for corticosteroids. * absolute neutrophil count greater than 0.5x106/l. * estimated creatinine clearance greater than 30 ml/minute. * written informed consent exclusion criteria: * patient receiving either infliximab or daclizumab within seven days of study. * patient with uncontrolled infections will be excluded. * patients receiving other investigational agents for gvhd prophylaxis or treatment. * patients with congestive heart failure. * patients with history of intolerance/ hypersensitivity to daclizumab or infliximab. * age less than 18 years. * patients who are pregnant or at risk of pregnancy and unwilling to use acceptable birth control methods. * patients with an allergy to murine products.
opioid-free anesthesia for open cardiac surgery: a prospective randomized controlled trial

Conditions: Opioid Use; Heart; Surgery, Heart, Functional Disturbance as Result; Anesthesia

Summary: this study will compare an opioid free anesthetic, using dexmedetomidine, to a traditional opioid based anesthetic, using fentanyl, for patients undergoing cardiac surgery with regards to hemodynamic stability in the first 10 minutes after induction.

this is a single center, blinded, prospective, randomized controlled trial. a total of 158 subjects (79 subjects in each arm) are planned. the control group will receive a traditional cardiac anesthetic using opioids, for which induction will include fentanyl and propofol. the experimental arm will receive an opioid free anesthetic with an induction bolus of dexmedetomidine and propofol. the investigators hypothesize that using the opioid free technique will be more hemodynamically stable within the first 10 minutes of induction.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 years of age at the time of consent. * undergoing non-emergent open cardiac procedures requiring cardiopulmonary bypass support, including: cabg, aortic aneurysm repair, valve repair/replacement, or cabg in combination with valve repair/replacement. * ability and willingness to provide written informed consent. exclusion criteria: * chronic opioid use defined as preoperative med \>100 daily. * hypersensitivity or contraindication to any of the study medications. * pre-existing alzheimer's/vascular dementia. * pre-existing psychiatric disorder precluding ability to provide informed consent or use a visual analogue scale for pain. * childs-pugh class c liver failure or acute liver failure. * emergent open heart surgery, including type a aortic dissections, trauma, or conversion (bail out) from another procedure such as cardiac catheterization, ablation, transcatheter aortic valve replacement or any other general surgical procedure. * pregnancy or lactating. * inability to comply with the requirements of the study, per investigator judgment. * patients determined to need an awake intubation.

Keywords: opioid free anesthesia cardiac surgery non-opioid anesthesia dexmedetomidine hemodynamic opioid fentanyl cardiac anesthesia cardiopulmonary bypass post sternotomy pain
response to clenbuterol in humans

Conditions: Healthy

Summary: due to the long half-life (\~36 hr) of clenbuterol, detection methods such as dried blood spots (dbs) are a potentially suitable method to easily and non-invasively detect doping misuse of this compound for several days after ingestion. if, and how long, the compound can be detected by dbs has not yet been investigated but is of interest due to its potential in doping-control. the aim is to evaluate whether abuse of clenbuterol can be detected at relevant concentration levels in samples obtained using dbs and to assess the physiological response to clenbuterol in skeletal muscle..


Eligibility criteria:
inclusion criteria: * healthy * male * 18-40 years of age * no known contraindications for anabolic drugs (e.g. cancer) exclusion criteria: * abnormal ecg * steroid abuse * ongoing use of prescription medication * heavy resistance training more than 2 times weekly * disease deemed by the md to infer a risk to participate in the trial

Keywords: dried blood spots skeletal muscle biopsies muscle strength muscle signaling
study to evaluate efficacy and safety of two drug regimens in subjects with moderate to severe crohn's disease

Conditions: Crohn's Disease

Summary: this study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active crohn's disease and evidence of mucosal ulceration.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease (cd) for at least 90 days, confirmed by endoscopy during the screening period. * active cd with a crohn's disease activity index (cdai) despite treatment with oral corticosteroids and/or immunosuppressants. * mucosal ulceration on endoscopy. exclusion criteria: * subject with ulcerative colitis or indeterminate colitis. * subject who has had surgical bowel resections in the past 6 months or is planning resection. * subjects with an ostomy or ileoanal pouch. * subject with symptomatic bowel stricture or abdominal or peri-anal abcess. * subject who has short bowel syndrome. * chronic recurring infections or active tuberculosis (tb).

Keywords: crohn's disease
multicenter study on the role of neurodegeneration biomarkers in obstructive sleep apnea syndrome with residual excessive daytime sleepiness.

Conditions: Sleep Apnea Syndromes

Summary: excessive daytime sleepiness which still remains after an effective treatment with nocturnal ventilotherapy or with other specific treatments (positional therapy, oro-mandibular devices) in patients with obstructive sleep apnea syndrome has a prevalence of 55% of treated cases, representing a notable theme of clinical and research interest. in recent years there have been several studies on the use of wakefulness-promoting drugs generally prescribed in patients with narcolepsy, in this disorder with promising results. right in consideration of the forthcoming approval of these drugs, it is important to find biomarkers able to predict which patients will develop daytime sleepiness resistant to ventilatory treatment. several studies have highlighted the association between obstructive sleep apnea syndrome and the increase of cerebral amyloid beta deposits, concluding that apnoic disorder can be considered a risk factor for the development of cognitive impairment and alzheimer';s disease. in this scenario, it would be useful to identify biological markers able to underline which clinical phenotypes of sleep apnea syndrome are more associated with residual excessive daytime sleepiness and/or cognitive impairment. in recent years several kits for the assay of biomarkers of neurodegeneration have been developed not only in csf, but also in human serum. among them, the most important are light chain neurofilaments (nfl), amyloid isoforms 40 and 42 (ab40 and ab42). other biomarkers found in neurodegenerative diseases associated with excessive daytime sleepiness are orexin a (oxa) and histamine (ha). in this view, the aim of this study is to evaluate the role of biomarkers of neurodegeneration in characterizing disease severity and response to treatment of obstructive sleep apnea syndrome with residual excessive daytime sleepiness.


Eligibility criteria:
inclusion criteria: * mild or moderate-severe obstructive sleep apnea * written informed consent exclusion criteria: * other sleep disorders * pregnancy or breastfeeding * cerebral diseases or neuropsychiatric deficits * psychiatric disorders * impossibility to provide informed consent

Keywords: hypersomnia excessive daytime sleepiness neurodegeneration biomarkers
qeeg and qualitative eeg for the identidification of abnormal patterns in fibromyalgia patients

Conditions: Fibromyalgia

Summary: fibromyalgia is a relatively young condition recently recognized by the who as a separated clinical entity. part of the medical comunity thinks of it as a mixed condition between depresion and rheumatic pain, however, functional data provided by sophisticated imaging techniques points at a diminished brain activity in several brain regions. the present study aims to characterize those findings by means of qeeg in order to establish the electroencephalographic characteristics of fibromyalgia patients.

fibromyalgia is a disease that part of the general population and even the medical community views with skepticism and only recently was accepted as a true condition by the world health organization. some physicians see it as a form of depresion mixed with rheumatic pain. however recent findings in functional magnetic resonance imaging and positron emited tomography documented diminished brain activity on several regions. the impairments must be located within the areas with a documented functional defect, wherein, spontaneous braincells activity chould arise. therefor electroencephalography findings should be a valuable diagnostic tool for early detection in fibromyalgia. the present study aims to analyse the differences between bioelectric characteristics in eeg from fibromyalgia patients with their eyes closed in a 21 electrode arragement. normal graphoelements as well as abnormal ones and its topographic distribution and functional conections will be analyzed. the working hypotesis is that fibromyalgia patients will present distintive characteristics in the same areas where a diminished brain activity has been documented by metabolic and morphologic tests as a group and that those characteristics are suitable to be measured by qeeg and distinguishable from healthy subjects.

Eligibility criteria:
inclusion criteria: * men and women between 20 and 70 years old, diagnosed with fibromyalgia and a control group matched by age and gender exclusion criteria: * any other concomitant neurologic disease or impairment

Keywords: fibromyalgia qeeg brain activity fmri diagnosis
a study to compare two techniques for the reconstruction of the anterior cruciate ligament

Conditions: Complete Tear, Knee, Anterior Cruciate Ligament

Summary: this is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy. the experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .


Eligibility criteria:
inclusion criteria: * age between 18 and 55 * mri confirmed primary and total acl injury of traumatic origin * indication for acl reconstruction in arthroscopy * written informed consent * active and non-sedentary lifestyle exclusion criteria: * complex meniscal injuries * cartilage lesions of sizes\> 2 cm2 * other ligamentous lesions * axis deviations greater than 10° * rheumatic, neuromuscular or general systemic diseases * prevention of injured knee traumas treated surgically * difficulties in compliance in following the rehabilitation programs * obesity (bmi ≥ 30) * neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients

Keywords: arthroscopy
covid-19 related health and infection control practices among dentists

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2

Summary: as dentists begin reopening their practices during a global pandemic, the risk of covid-19 infection that dentists face in providing dental care remains unknown. estimating the occupational risk of covid-19, and producing evidence on the types of infection control practices and dental practices that may affect covid-19 risk, is therefore imperative. the goal of the proposed study is to understand u.s.-based dentists' health and dental-practice reactions to covid-19. to estimate this, u.s-based dentists will be surveyed monthly. these findings could be used to describe the prevalence and incidence of covid-19 among dentists, determine what infection control steps dentists take over time, and estimate whether infection control adherence in dental practice is related to covid-19 incidence.


Eligibility criteria:
inclusion criteria: * primary dental practice is in united states * 18 years of age or older * dentist exclusion criteria: •answered "no" to ada survey sent may 2020 that read "as part of ongoing efforts to monitor the effect of covid-19 on the dental team, the ada is interested in collecting data related to infection rates. would you also be willing to participate in a separate, longitudinal study that would require you to report whether you or your staff have exhibited symptoms of covid-19, and whether you have been tested or diagnosed? the study would be anonymous and under irb protocols."

Keywords: sars-cov-2 covid-19 survey dentistry infection control
integration of telemedicine and home-based cardiac rehabilitation: feasibility, efficacy, and adherence

Conditions: Myocardial Infarction; Percutaneous Transluminal Coronary Angioplasty; Coronary Artery Bypass; Stable Angina; Heart Failure; Valve Disease, Heart; Cardiac Rehabilitation; Stent

Summary: the aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. several components will be assessed such as quality-of-life, nutritional counseling, maximum metabolic activity (met's), diabetic management, tobacco cessation, lipid, blood pressure, and psychosocial management. these tasks will be accomplished through concurrent conversations between patients and their therapist's utilizing telemedicine with observed exercise training.

the focus of this study is to determine the feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine. the study consists of an initial review, rehabilitation sessions, nutrition consultation, and risk stratification. once the patient is cleared for the rehabilitation program, they will be assigned a cardiac rehab specialist and begin the 36 rehabilitation sessions. the sessions include pre-session questions, surveys, pre-, during, and post vitals, exercise protocol, and off-the-device exercises.

Eligibility criteria:
inclusion criteria: 1. over the age of 18 2. nyha functional class i, ii, 3. recent (within 60 days) status post coronary artery revascularization for atherosclerotic coronary artery disease (coronary artery bypass grafting or percutaneous coronary revascularization with stent implantation) 4. candidate for traditional center-based cardiac rehabilitation exclusion criteria: 1. under the age of 18 2. adults lacking capacity to consent. 3. nyha functional class iii, iv 4. acute coronary syndrome 5. systolic heart failure (lv ef \<40%) 6. status post cardiac surgery for structural heart disease or heart transplant 7. percutaneous coronary angioplasty 8. adults lacking capacity to consent. 9. pregnant women

Keywords: cardiac rehabilitation home based cardiac rehabilitation telemedicine and home-based cardiac rehabilitation
effectiveness of a triple nutritional intervention and physical in prediabetic patienrs

Conditions: Diabetes

Summary: diabetes represents a substantial burden on health care systems. people with prediabetes igt (impaired glucose tolerance) or ifg (impaired fasting glucose) are at high risk of developing diabetes, and up to 50% progress to diabetes within 5 years. objective: to evaluate the effectiveness of a triple intervention (physical activity and ordered healthy diet) to improve glycosylated hemoglobin control in prediabetic patients. material and methodology: randomized, open, controlled clinical trial with routine clinical practice (health advice for physical activity and healthy diet). study population: obese or overweight patients of the osi araba aged 35-70 years who are in the contemplation stage. response assessment: primary variable: glycosylated hemoglobin; secondary variables: body mass index (bmi) (kg/cm2); blood pressure (mm hg); satisfaction questionnaire score; physical exercise index (ipaq) (mets). statistical analysis: the analysis of the main variable (change in hba1c at 6 months between both groups) will be assessed by analysis of covariance, ancova, adjusting for baseline hba1c. sample size: 41 patients per arm (+30% to cover losses to follow-up).


Eligibility criteria:
inclusion criteria: prediabetics with glycosylated hemoglobin (hba1c) 5.7-6.4 (24, 38) and signing informed consent. - exclusion criteria: presence of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as gliflozin for pathologies other than diabetes mellitus. of physical or psychological illnesses that prevent physical activity; participation in another research project; pregnancy or breastfeeding; patients undergoing dietary or pharmacological treatment for weight loss; history of myocardial infarction or stroke; diabetic, taking drugs for diabetes mellitus and taking drugs such as gliflozin for pathologies other than diabetes mellitus.

Keywords: diabetes mellitus
a study of bms-833923 with carboplatin and etoposide followed by bms-833923 alone in subjects with extensive-stage small cell lung cancer

Conditions: Small Cell Lung Carcinoma

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) of bms-833923 administered in combination with carboplatin and etoposide followed by bms-833923 alone in subjects with extensive-stage small cell lung cancer (sclc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed small cell lung cancer, without prior chemotherapy treatment * men and women at least 18 years old * eastern cooperative oncology group (ecog) status 0-2 exclusion criteria: * significant cardiovascular disease * prior treatment of small cell lung cancer is not permitted, except for palliative radiation to a limited field excluding the chest (e.g. for painful metastasis). * symptomatic brain metastases * women pregnant or breastfeeding * women of childbearing potential (wocbp) unwilling/unable to use acceptable method to avoid pregnancy * uncontrolled medical disorder or active infection * concurrent therapy with any other investigational product
effectiveness and safety of once or twice daily mometasone nasal spray versus amoxicillin versus placebo for treatment of acute rhinosinusitis (phase 3 study)(study p02692)

Conditions: Acute Rhinosinusitis

Summary: this study was conducted to compare the effectiveness and safety of mometasone nasal spray once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms of acute rhinosinusitis. patients received mometasone nasal spray 2 sprays per nostril once daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo three times a day. patients on nasal spray were treated for 15 days and patients on amoxicillin or placebo were treated for 10 days. all patients were followed-up with a 14-day no-treatment observation period.


Eligibility criteria:
inclusion criteria: subjects must: * have been diagnosed with acute rhinosinusitis * have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to baseline * have had a major symptom score \>=5 and \<=12 at the screening and baseline, and no more than 3 of the 5 major individual symptoms were to be rated as "severe" * be \>=12 years old * be in good health overall and normal laboratory tests * not be pregnant, intending to become pregnant or intending to impregnate. exclusion criteria: subjects who: * have a history of chronic rhinosinusitis or who had undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to screening * have fever \>=101°f and/or persistent severe unilateral facial pain/tooth pain; and/or orbital or peri-orbital facial swelling; and/or dental involvement; and/or worsening symptoms after initial improvement * have a history of symptomatic seasonal allergic rhinitis who were exposed to allergenic pollens * have asthma with fev1\<65% of predicted volume in the past 3 months or who have had an exacerbation within the past 30 days * have nasal polyps, kartagener's syndrome, and otitis or atrophic rhinitis * have certain comorbid conditions or contraindications to certain drug therapies
efficacy and safety of a retinoid for the treatment of severe chronic hand dermatitis

Conditions: Hand Dermatoses

Summary: the purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

chronic hand dermatitis (chad) is a frequent and distressing disease. conventional treatments yield mostly unsatisfactory results. in addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. in a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment. patients with severe refractory chad will be allocated either of two active treatments or placebo. the primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

Eligibility criteria:
inclusion criteria: * chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis * lasting for 6 months since initial diagnosis * rated severe * refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens * refractory to topical steroids exclusion criteria: * female patients who are pregnant or want to become pregnant * female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously * patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy

Keywords: chronic hand dermatitis